CERo Therapeutics has completed the first cohort of its Phase I study of CER-1236 involving participants diagnosed with acute myeloid leukaemia (AML).
This conclusion comes after observing cell expansion that aligns with preclinical expectations, with no dose-limiting toxicities reported.
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CERo selected the initial dose for cohort one that was the same as the standard dose used in CAR T therapy for individuals with B-cell lymphoma, where toxicity is typically managed and frequently encountered in a hospital setting.
As the company continues its investigations into optimal dosing, additional dose infusions have been given to the second and third participants.
Based on encouraging pharmacokinetic outcomes and interest from the subject and treating physician, the company plans to provide an additional infusion of CER-1236 to the second participant of cohort one.
This approach aims to explore whether multiple infusions could offer an alternative to dose intensification achieved through one, larger initial dose.
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By GlobalDataCERo chief medical officer Robert Sikorski said: “Completion of the first cohort without any dose-limiting toxicities and in-vivo cell expansion of CER-1236 therapeutic cells represent important early steps in this study.
“The data collected to date support moving to the next planned dose level in accordance with the trial protocol. As we advance, we will continue close safety monitoring and systematic evaluation of pharmacokinetic and clinical data to inform subsequent stages of development.”
The open-label, multi-centre, first-in-human Phase I/Ib trial aims to assess the preliminary efficacy and safety of CER-1236 in individuals with AML who are either relapsed/refractory, in remission with measurable residual disease, or newly diagnosed harbouring TP53 mutations.
It consists of two parts: the initial dose escalation phase seeks to establish the recommended dose as well as the highest tolerated dose for Phase II, and an expansion phase will follow to further evaluate both efficacy and safety.
Serious adverse events, the incidence of adverse events, the estimation of the overall response rate, the incidence of dose-limiting toxicities, measurable residual disease, composite complete response and complete response are the primary outcome measures.
The secondary outcome measures focus on pharmacokinetics (PK).
